Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions, no monitoring of saturated atmosphere.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Method: other: in house protocol
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory (Tunstall) Breeding Unit,  Sittingbourne, Kent, UK
- Age at study initiation: 8 weeks approx.
- Weight at study initiation: not reported 
- Housing: after exposure the animals were individually housed in hanging polypropylene cages with stainless steel wire mesh floor and top
- Diet: ad libitum, except during exposure
- Water: ad libitum, except during exposure



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: Condensation mist atmosphere
Details on inhalation exposure:
- Concentrations: saturated atmosphere (no monitoring reported)
- Particle size: not reported
- Type or preparation of particles: condensation mist
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
saturated atmosphere
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial,  7 and 14 day bodyweights were recorded.
- Necropsy of survivors performed: no


Results and discussion

Effect levels
Effect level:
> 10 000 000 000 mg/L air
Remarks on result:
other: = LC50 >saturated vapour concentration
Mortality:
All animals survived the 4 hour exposure and subsequent  observation period.
Clinical signs:
other: There were no signs of toxicity during or after exposure.
Body weight:
Not reported.
Gross pathology:
Not carried out.
Other findings:
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 4 hour rat inhalational LC50 for Dobanol 25 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..